Director, CMC Regulatory

Position Overview:

The Director, CMC Regulatory is responsible for developing, leading, and executing regulatory strategies that support Chemistry, Manufacturing, and Controls (CMC) requirements for the company’s product portfolio. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of CMC regulatory activities throughout the product lifecycle.

This is a full-time position and may be performed remotely from any location within the continental U.S.. The position will report to the Senior Vice President, Head of CMC.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• Regulatory Strategy & Submissions
• - Develop and implement global regulatory strategies for CMC aspects of drug development, including clinical trials, marketing applications, and post-approval changes.
• Lead CMC submissions (IND, NDA, BLA, MAA, etc.) in collaboration with Regulatory Affairs and project teams, ensuring compliance with FDA, EMA, and other regulatory authorities, and to lead any agency CMC interactions.
• Guide the creation and market entry of pharmaceutical products, maintaining a balance between innovation and regulatory compliance, including maintaining and extending product registrations in US, Europe and ROW.
• Support the regulatory submission forms to support regulatory release and QP certification.
• Provide expertise in authoring, reviewing, and approving CMC sections for regulatory submissions, amendments, supplements, and variations.
• Provide guidance with regards to post-approval Regulatory CMC Strategy including commercialization, product launch and post-marketing commitments.
• Provide expertise in regulatory CMC strategy for a drug device combination package including responsibility for module 3.2.R., 21 CFR part 820.30 or ISO 13485
• Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
• Collaboration & Communication
• - Serve as a primary CMC regulatory contact with health authorities and provide responses to queries.
• Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes.
• As the global CMC/quality regulatory expert, ensure any necessary knowledge is transferred throughout the Regulatory team and internal stakeholders.
• Work closely with internal departments such as Quality, Clinical, Manufacturing, and Supply Chain to align on regulatory strategies and ensure timely submission of CMC documents.
• Communicate and collaborate with external partners, contract manufacturers, and consultants to ensure regulatory compliance and alignment with corporate objectives.
• Strong ability to communicate at all levels with clarity and precision.
• Regulatory Intelligence & Compliance
• - Stay current with global regulatory guidelines, standards, and industry practices relevant to CMC, assessing their impact on ongoing projects.
• Provide guidance and risk assessments on CMC regulatory matters to senior management and other stakeholders.
• Monitor and assess CMC regulatory compliance to ensure continuous alignment with regulatory expectations throughout the product lifecycle.
• Documentation & Project Management
• - Ensure all CMC documentation is accurate, complete, and in compliance with regulatory requirements.
• Lead project teams in the development of regulatory documents, timelines, and deliverables, ensuring efficient execution and clear communication of progress and challenges.
• Conduct periodic reviews of CMC documentation and processes to drive improvements and ensure adherence to best practices.

Qualifications:

• Advanced degree (Ph.D., MS, or equivalent) in chemistry, pharmaceutical sciences, or a related field.
• 8+ years of experience in Regulatory Affairs with a focus on CMC in the biotech or pharmaceutical industry.
• In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, ICH) relevant to CMC.
• Proven experience with successful CMC regulatory submissions and post-approval activities.

• Strong project management and organizational skills, with attention to detail.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.

Compensation and Benefits

What we offer:

• Industry competitive compensation
• Performance-based bonuses
• Stock options
• Employee Stock Purchase Plan
• 401k plan
• A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings and AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-life balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid holidays
• Mental health days
• Winter shutdown
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $180,000-$215,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

OVERVIEW OF THE COMPANY

Connect at www.vistagen.com.